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  </head><body onload="reset_menus();"><div id="menu"><a name="top" class="invisible" href="#main">Skip Navigation Link</a><span class="study-name">8326556</span><ul class="hmenu"><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a class="tocItem">Supplemental Documents</a><ul><li class="hmenu-item"><span class="hmenu-bullet">+</span><a class="external tocItem" href="nsdrg.pdf">nSDRG</a><span class="external-link-gif"></span></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#datasets">Datasets</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.CO">CO (Comments)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DM">DM (Demographics)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SE">SE (Subject Elements)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.EX">EX (Exposure)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.DS">DS (Disposition)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.BW">BW (Body Weight)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.BG">BG (Body Weight Gains)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.CL">CL (Clinical Observations)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.LB">LB (Laboratory)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TA">TA (Trial Arms)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TE">TE (Trial Elements)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TX">TX (Trial Sets)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.TS">TS (Trial Summary)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPBW">SUPPBW (Supplemental Body Weight)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPBG">SUPPBG (Supplemental Body Weight Gain)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPCL">SUPPCL (Supplemental Clinical Observations)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPDS">SUPPDS (Supplemental Disposition)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.SUPPLB">SUPPLB (Supplemental Laboratory Test Results)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.8d086f3d-854e-4e50">IS (Immunogenicity Specimen Assessments)</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#IG.IG.71c8c332-b176-474b">SUPPIS (Supplemental Immunogenicity Specimen)</a></li></ul></li><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">+</span><a href="#decodelist" class="tocItem">Controlled Terminology</a><ul><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#decodelist">CodeLists</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.AGEU">Age Unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.BGTEST">Body Weight Gain Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.BGTESTCD">Body Weight Gain Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.BWTEST">Body Weight Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.BWTESTCD">Body Weight Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CLCAT">Category for Clinical Observation</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CLSCAT">CLSCAT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CLTEST">CLTEST</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CLTESTCD">CLTESTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.COUNTRY">Country</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.DESIGN">Study Design</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.DSDECOD">Standardized Disposition Term</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.FREQ">Frequency</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.FRM">Pharmaceutical Dosage Form</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.LBCAT">LBCAT</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.LBTEST">Laboratory Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.LBTESTCD">Laboratory Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.NULLFLAV">Null Flavor Reason</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.NY">No Yes Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.ROUTE">Route of Administration Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SDOMAIN">SEND Domain Abbreviation</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SEX">Sex</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SEXPOP">Sex of Participants Response</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SNDIGVER">SEND Implementation Guide Version</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SPEC">Specimen</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SPECIES">Species</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.SSTYP">SEND Study Type</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.STCAT">Study Category</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.STRAIN">Strain/Substrain</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.STSPRM">SEND Trial Summary Parameter Test Name</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.STSPRMCD">SEND Trial Summary Parameter Test Code</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.UNIT">Unit</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.fe7e121a-b0cc-4796">ISTEST</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.86d1da8a-8d6c-4216">ISTESTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#CL.CL.d2fca64d-a119-4bce">IS.UNIT</a></li></ul></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">+</span><a class="tocItem" href="#compmethod">Methods</a><ul><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.198dd982-83df-4c2f">VISITDY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.492f0579-b8b4-46d7">BLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.55d89e07-ae3d-4af3">ENDY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.5df06289-8457-4ce2">DY</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.8c39d4b3-9f3b-4e22">NOMLBL</a></li><li class="hmenu-item"><span class="hmenu-bullet">-</span><a class="tocItem" href="#MT.MT.cbb773ad-9a50-463e">NOMDY</a></li></ul></li></ul><div class="buttons"><div class="button"><button type="button" onclick="expand_all_vlm();">Expand all VLM</button></div><div class="button"><button type="button" onclick="collapse_all_vlm();">Collapse all VLM</button></div></div></div><div id="main"><div class="docinfo"><p class="documentinfo">Date/Time of Define-XML document generation: 2019-10-03T20:06:25</p><p class="documentinfo">Define-XML version: 2.0.0</p><p class="stylesheetinfo">Stylesheet version: 2018-11-21</p></div><div class="study-metadata"><dl class="study-metadata"><dt>Standard</dt><dd>SEND-IG 3.1</dd><dt>Study Name</dt><dd>8326556</dd><dt>Study Description</dt><dd>Characterization of Hepatitis B vaccine T-Cell Dependent Antibody Response in Cynomolgus Monkeys</dd><dt>Protocol Name</dt><dd>8326556</dd><dt>Metadata Name</dt><dd>Study 8326556,Data Definitions</dd><dt>Metadata Description</dt><dd>Study 8326556,Data Definitions</dd></dl></div><a id="datasets"></a><h1 class="invisible">Datasets</h1><div class="containerbox"><table summary="Data Definition Tables"><caption class="header">Datasets</caption><tr class="header"><th scope="col">Dataset</th><th scope="col">Description</th><th scope="col">Class
            </th><th scope="col">Structure</th><th scope="col">Purpose</th><th scope="col">Keys</th><th scope="col">Documentation</th><th scope="col">Location</th></tr><tr class="tablerowodd" id="IG.CO"><td><a href="#IG.IG.CO">CO</a></td><td>Comments</td><td>SPECIAL PURPOSE</td><td>One record per comment</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, CODTC</td><td></td><td><a class="external" href="co.xpt">co.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.DM"><td><a href="#IG.IG.DM">DM</a></td><td>Demographics</td><td>SPECIAL PURPOSE</td><td>One record per subject</td><td>Tabulation</td><td>STUDYID, USUBJID</td><td></td><td><a class="external" href="dm.xpt">dm.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SE"><td><a href="#IG.IG.SE">SE</a></td><td>Subject Elements</td><td>SPECIAL PURPOSE</td><td>One record per element experienced per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, ETCD, SESTDTC</td><td></td><td><a class="external" href="se.xpt">se.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.EX"><td><a href="#IG.IG.EX">EX</a></td><td>Exposure</td><td>INTERVENTIONS</td><td>One record per constant dosing interval per treatment per subject or pool</td><td>Tabulation</td><td>STUDYID, USUBJID, EXTRT, EXSTDTC</td><td></td><td><a class="external" href="ex.xpt">ex.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.DS"><td><a href="#IG.IG.DS">DS</a></td><td>Disposition</td><td>EVENTS</td><td>One record per subject</td><td>Tabulation</td><td>STUDYID, USUBJID</td><td></td><td><a class="external" href="ds.xpt">ds.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.BW"><td><a href="#IG.IG.BW">BW</a></td><td>Body Weight</td><td>FINDINGS</td><td>One record per test per observation time per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, BWTESTCD, BWDTC</td><td></td><td><a class="external" href="bw.xpt">bw.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.BG"><td><a href="#IG.IG.BG">BG</a></td><td>Body Weight Gains</td><td>FINDINGS</td><td>One record per test per interval per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, BGTESTCD, BGDTC, BGENDTC</td><td></td><td><a class="external" href="bg.xpt">bg.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.CL"><td><a href="#IG.IG.CL">CL</a></td><td>Clinical Observations</td><td>FINDINGS</td><td>One record per finding per observation time per subject</td><td>Tabulation</td><td>STUDYID, USUBJID, CLTESTCD, CLCAT, CLORRES, CLLOC, CLDTC, CLSCAT, CLTPTNUM</td><td></td><td><a class="external" href="cl.xpt">cl.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.LB"><td><a href="#IG.IG.LB">LB</a></td><td>Laboratory</td><td>FINDINGS</td><td>One record per test per specimen per observation time per subject or pool</td><td>Tabulation</td><td>STUDYID, USUBJID, LBTESTCD, LBSPEC, LBDTC, LBTPTNUM, LBCAT, LBMETHOD, LBTPT</td><td></td><td><a class="external" href="lb.xpt">lb.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.TA"><td><a href="#IG.IG.TA">TA</a></td><td>Trial Arms</td><td>TRIAL DESIGN</td><td>One record per planned Element per Arm</td><td>Tabulation</td><td>STUDYID, ARMCD, TAETORD</td><td></td><td><a class="external" href="ta.xpt">ta.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.TE"><td><a href="#IG.IG.TE">TE</a></td><td>Trial Elements</td><td>TRIAL DESIGN</td><td>One record per planned Element</td><td>Tabulation</td><td>STUDYID, ETCD</td><td></td><td><a class="external" href="te.xpt">te.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.TX"><td><a href="#IG.IG.TX">TX</a></td><td>Trial Sets</td><td>TRIAL DESIGN</td><td>One record per Trial Set parameter per Trial Set</td><td>Tabulation</td><td>STUDYID, SETCD, TXPARMCD</td><td></td><td><a class="external" href="tx.xpt">tx.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.TS"><td><a href="#IG.IG.TS">TS</a></td><td>Trial Summary</td><td>TRIAL DESIGN</td><td>One record per Trial Summary parameter value</td><td>Tabulation</td><td>STUDYID, TSPARMCD, TSGRPID</td><td></td><td><a class="external" href="ts.xpt">ts.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.SUPPBW"><td><a href="#IG.IG.SUPPBW">SUPPBW</a></td><td>Supplemental Body Weight (Body Weight)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppbw.xpt">suppbw.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SUPPBG"><td><a href="#IG.IG.SUPPBG">SUPPBG</a></td><td>Supplemental Body Weight Gain (Body Weight Gains)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppbg.xpt">suppbg.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.SUPPCL"><td><a href="#IG.IG.SUPPCL">SUPPCL</a></td><td>Supplemental Clinical Observations (Clinical Observations)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppcl.xpt">suppcl.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.SUPPDS"><td><a href="#IG.IG.SUPPDS">SUPPDS</a></td><td>Supplemental Disposition (Disposition)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="suppds.xpt">suppds.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.SUPPLB"><td><a href="#IG.IG.SUPPLB">SUPPLB</a></td><td>Supplemental Laboratory Test Results (Laboratory)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL, QNAM</td><td></td><td><a class="external" href="supplb.xpt">supplb.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.8d086f3d-854e-4e50"><td><a href="#IG.IG.8d086f3d-854e-4e50">IS</a></td><td>Immunogenicity Specimen Assessments</td><td>FINDINGS</td><td>One record per test per specimen per observation time per subject or pool</td><td>Tabulation</td><td>STUDYID, USUBJID, ISTESTCD, ISDY</td><td></td><td><a class="external" href="is.xpt">is.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.71c8c332-b176-474b"><td><a href="#IG.IG.71c8c332-b176-474b">SUPPIS</a></td><td>Supplemental Immunogenicity Specimen (Immunogenicity Specimen Assessments)</td><td>RELATIONSHIP</td><td>One record per supplemental qualifier per related parent domain record(s)</td><td>Tabulation</td><td>STUDYID, RDOMAIN, USUBJID, IDVAR, IDVARVAL</td><td></td><td><a class="external" href="suppis.xpt">suppis.xpt</a><span class="external-link-gif"></span> </td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.CO"></a><div class="containerbox"><h1 class="invisible">Comments (CO) </h1><table summary="ItemGroup IG.IG.CO"><caption><span>CO (Comments) - SPECIAL PURPOSE <span class="dataset">Location: <a class="external" href="co.xpt">co.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.CO.IT.CO.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CO.IT.CO.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CO.IT.CO.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CO.IT.CO.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CO.IT.CO.COSEQ"></a>COSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CO.IT.CO.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CO.IT.CO.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CO.IT.CO.COVAL"></a>COVAL</td><td>Comment</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">10</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.CO.IT.CO.CODTC"></a>CODTC</td><td>Date/Time of Comment</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.CO.IT.CO.CODY"></a>CODY</td><td>Study Day of Comment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DM"></a><div class="containerbox"><h1 class="invisible">Demographics (DM) </h1><table summary="ItemGroup IG.IG.DM"><caption><span>DM (Demographics) - SPECIAL PURPOSE <span class="dataset">Location: <a class="external" href="dm.xpt">dm.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">6</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.RFSTDTC"></a>RFSTDTC</td><td>Subject Reference Start Date/Time</td><td class="datatype">datetime</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.RFENDTC"></a>RFENDTC</td><td>Subject Reference End Date/Time</td><td class="datatype">datetime</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.RFXSTDTC"></a>RFXSTDTC</td><td>Date/Time of First Study Treatment</td><td class="datatype">datetime</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.RFXENDTC"></a>RFXENDTC</td><td>Date/Time of Last Study Treatment</td><td class="datatype">datetime</td><td class="role">Record Qualifier</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.AGETXT"></a>AGETXT</td><td>Age Range</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.AGEU"></a>AGEU</td><td>Age Unit</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.AGEU">Age Unit</a></span><ul class="codelist"><li class="codelist-item">• "YEARS"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.SEX">Sex</a></span><ul class="codelist"><li class="codelist-item">• "F" = "A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI)"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.ARMCD"></a>ARMCD</td><td>Planned Arm Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DM.IT.DM.ARM"></a>ARM</td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DM.IT.DM.SETCD"></a>SETCD</td><td>Set Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SE"></a><div class="containerbox"><h1 class="invisible">Subject Elements (SE) </h1><table summary="ItemGroup IG.IG.SE"><caption><span>SE (Subject Elements) - SPECIAL PURPOSE <span class="dataset">Location: <a class="external" href="se.xpt">se.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.SESEQ"></a>SESEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">36</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SE.IT.SE.SESTDTC"></a>SESTDTC</td><td>Start Date/Time of Element</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.SE.IT.SE.SEENDTC"></a>SEENDTC</td><td>End Date/Time of Element</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.EX"></a><div class="containerbox"><h1 class="invisible">Exposure (EX) </h1><table summary="ItemGroup IG.IG.EX"><caption><span>EX (Exposure) - INTERVENTIONS <span class="dataset">Location: <a class="external" href="ex.xpt">ex.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXSEQ"></a>EXSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXTRT"></a>EXTRT</td><td>Name of Actual Treatment</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">19</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXDOSE"></a>EXDOSE</td><td>Dose per Administration</td><td class="datatype">float</td><td class="role">Record Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXDOSU"></a>EXDOSU</td><td>Dose Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXDOSFRM"></a>EXDOSFRM</td><td>Dose Form</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.FRM">Pharmaceutical Dosage Form</a></span><ul class="codelist"><li class="codelist-item">• "SOLUTION"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXDOSFRQ"></a>EXDOSFRQ</td><td>Dosing Frequency Per Interval</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.FREQ">Frequency</a></span><ul class="codelist"><li class="codelist-item">• "TWICE"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXROUTE"></a>EXROUTE</td><td>Route of Administration</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">13</td><td><span class="linebreakcell"><a href="#CL.ROUTE">Route of Administration Response</a></span><ul class="codelist"><li class="codelist-item">• "INTRAMUSCULAR"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXLOT"></a>EXLOT</td><td>Lot Number</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXTRTV"></a>EXTRTV</td><td>Treatment Vehicle</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.EX.IT.EX.EXSTDTC"></a>EXSTDTC</td><td>Start Date/Time of Treatment</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.EX.IT.EX.EXSTDY"></a>EXSTDY</td><td>Study Day of Start of Treatment</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.DS"></a><div class="containerbox"><h1 class="invisible">Disposition (DS) </h1><table summary="ItemGroup IG.IG.DS"><caption><span>DS (Disposition) - EVENTS <span class="dataset">Location: <a class="external" href="ds.xpt">ds.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPDS">SUPPDS</a> (Supplemental Disposition)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSSEQ"></a>DSSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSTERM"></a>DSTERM</td><td>Reported Term for the Disposition Event</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">9</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSDECOD"></a>DSDECOD</td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">24</td><td><span class="linebreakcell"><a href="#CL.DSDECOD">Standardized Disposition Term</a></span><ul class="codelist"><li class="codelist-item">• "REMOVED FROM STUDY ALIVE"</li></ul></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSUSCHFL"></a>DSUSCHFL</td><td>Unscheduled Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.VISITDY"></a>VISITDY</td><td>Planned Study Day of Disposition</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSSTDTC"></a>DSSTDTC</td><td>Date/Time of Disposition</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.DS.IT.DS.DSSTDY"></a>DSSTDY</td><td>Study Day of Disposition</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tablerowodd"><td><a id="IG.DS.IT.DS.DSNOMDY"></a>DSNOMDY</td><td>Nominal Study Day for Tabulations</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.BW"></a><div class="containerbox"><h1 class="invisible">Body Weight (BW) </h1><table summary="ItemGroup IG.IG.BW"><caption><span>BW (Body Weight) - FINDINGS <span class="dataset">Location: <a class="external" href="bw.xpt">bw.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPBW">SUPPBW</a> (Supplemental Body Weight)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWSEQ"></a>BWSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWTESTCD"></a>BWTESTCD</td><td>Test Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">2</td><td><span class="linebreakcell"><a href="#CL.BWTESTCD">Body Weight Test Code</a></span><ul class="codelist"><li class="codelist-item">• "BW" = "The weight of a subject. (NCI)"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWTEST"></a>BWTEST</td><td>Test Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">11</td><td><span class="linebreakcell"><a href="#CL.BWTEST">Body Weight Test Name</a></span><ul class="codelist"><li class="codelist-item">• "Body Weight"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWORRES"></a>BWORRES</td><td>Result or Findings as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWORRESU"></a>BWORRESU</td><td>Unit of the Original Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWSTRESC"></a>BWSTRESC</td><td>Standardized Result in Character Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWSTRESN"></a>BWSTRESN</td><td>Standardized Result in Numeric Format</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWSTRESU"></a>BWSTRESU</td><td>Unit of the Standardized Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWBLFL"></a>BWBLFL</td><td>Baseline Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.VISITDY"></a>VISITDY</td><td>Planned Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWDTC"></a>BWDTC</td><td>Date/Time Animal Weighed</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWDY"></a>BWDY</td><td>Study Day Animal Weighed</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tableroweven"><td><a id="IG.BW.IT.BW.BWNOMDY"></a>BWNOMDY</td><td>Nominal Study Day for Tabulations</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tablerowodd"><td><a id="IG.BW.IT.BW.BWNOMLBL"></a>BWNOMLBL</td><td>Label for Nominal Study Day</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">13</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Populated with the phase name and the planned date of data collection, in days from the phase start date.
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.BG"></a><div class="containerbox"><h1 class="invisible">Body Weight Gains (BG) </h1><table summary="ItemGroup IG.IG.BG"><caption><span>BG (Body Weight Gains) - FINDINGS <span class="dataset">Location: <a class="external" href="bg.xpt">bg.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPBG">SUPPBG</a> (Supplemental Body Weight Gain)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGSEQ"></a>BGSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGTESTCD"></a>BGTESTCD</td><td>Test Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.BGTESTCD">Body Weight Gain Test Code</a></span><ul class="codelist"><li class="codelist-item">• "BWGAIN" = "A change in overall body weight, relative to the beginning of the collection period."</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGTEST"></a>BGTEST</td><td>Test Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.BGTEST">Body Weight Gain Test Name</a></span><ul class="codelist"><li class="codelist-item">• "Body Weight Gain"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGORRES"></a>BGORRES</td><td>Result or Findings as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGORRESU"></a>BGORRESU</td><td>Unit of the Original Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGSTRESC"></a>BGSTRESC</td><td>Standardized Result in Character Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGSTRESN"></a>BGSTRESN</td><td>Standardized Result in Numeric Format</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGSTRESU"></a>BGSTRESU</td><td>Unit of the Standardized Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">2</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGDTC"></a>BGDTC</td><td>Date/Time Animal Weighed</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGENDTC"></a>BGENDTC</td><td>End Date/Time Animal Weighed</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.BG.IT.BG.BGDY"></a>BGDY</td><td>Study Day of Start of Interval</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tablerowodd"><td><a id="IG.BG.IT.BG.BGENDY"></a>BGENDY</td><td>Study Day of End of Weight Interval</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on End Date/Time of Animal Weighed minus Subject Reference Start Date/Time, plus one when occurring after Day 1. 
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.CL"></a><div class="containerbox"><h1 class="invisible">Clinical Observations (CL) </h1><table summary="ItemGroup IG.IG.CL"><caption><span>CL (Clinical Observations) - FINDINGS <span class="dataset">Location: <a class="external" href="cl.xpt">cl.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPCL">SUPPCL</a> (Supplemental Clinical Observations)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLSEQ"></a>CLSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLGRPID"></a>CLGRPID</td><td>Group Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLTESTCD"></a>CLTESTCD</td><td>Test Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CLTESTCD">CLTESTCD</a></span><ul class="codelist"><li class="codelist-item">• "CLNOB" = "An assessment of clinical observations."</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLTEST"></a>CLTEST</td><td>Test Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CLTEST">CLTEST</a></span><ul class="codelist"><li class="codelist-item">• "Clinical Observation"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLCAT"></a>CLCAT</td><td>Category for Clinical Observations</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.CLCAT">Category for Clinical Observation</a></span><ul class="codelist"><li class="codelist-item">• "CLINICAL SIGNS"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLSCAT"></a>CLSCAT</td><td>Subcategory for Clinical Observations</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">19</td><td><span class="linebreakcell"><a href="#CL.CLSCAT">CLSCAT</a></span><ul class="codelist"><li class="codelist-item">• "Discharge"</li><li class="codelist-item">• "Excretion"</li><li class="codelist-item">• "Physical Appearance"</li><li class="codelist-item">• "Vet Exam"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLORRES"></a>CLORRES</td><td>Result or Findings as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">50</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLSTRESC"></a>CLSTRESC</td><td>Standardized Result in Character Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">39</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLLOC"></a>CLLOC</td><td>Location of a Finding</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">16</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.VISITDY"></a>VISITDY</td><td>Planned Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLDTC"></a>CLDTC</td><td>Date/Time of Observation</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLDY"></a>CLDY</td><td>Study Day of Observation</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLNOMDY"></a>CLNOMDY</td><td>Nominal Study Day for Tabulations</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLNOMLBL"></a>CLNOMLBL</td><td>Label for Nominal Study Day</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">13</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Populated with the phase name and the planned date of data collection, in days from the phase start date.
</div></td></tr><tr class="tableroweven"><td><a id="IG.CL.IT.CL.CLTPT"></a>CLTPT</td><td>Planned Time Point Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.CL.IT.CL.CLTPTNUM"></a>CLTPTNUM</td><td>Planned Time Point Number</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.LB"></a><div class="containerbox"><h1 class="invisible">Laboratory (LB) </h1><table summary="ItemGroup IG.IG.LB"><caption><span>LB (Laboratory) - FINDINGS <span class="dataset">Location: <a class="external" href="lb.xpt">lb.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.SUPPLB">SUPPLB</a> (Supplemental Laboratory Test Results)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSEQ"></a>LBSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBGRPID"></a>LBGRPID</td><td>Group Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBREFID"></a>LBREFID</td><td>Specimen Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBTESTCD"></a>LBTESTCD</td><td>Lab Test or Examination Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><a href="#CL.LBTESTCD">Laboratory Test Code</a><p class="linebreakcell">
                  [65 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBTEST"></a>LBTEST</td><td>Lab Test or Examination Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">39</td><td><a href="#CL.LBTEST">Laboratory Test Name</a><p class="linebreakcell">
                  [65 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBCAT"></a>LBCAT</td><td>Category for Lab Test</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.LBCAT">LBCAT</a></span><ul class="codelist"><li class="codelist-item">• "CLINICAL CHEMISTRY"</li><li class="codelist-item">• "COAGULATION"</li><li class="codelist-item">• "HEMATOLOGY"</li><li class="codelist-item">• "URINALYSIS/URINE CHEMISTRY"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBORRES"></a>LBORRES</td><td>Result or Findings as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBORRESU"></a>LBORRESU</td><td>Unit of the Original Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSTRESC"></a>LBSTRESC</td><td>Standardized Result in Character Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBSTRESN"></a>LBSTRESN</td><td>Standardized Result in Numeric Format</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSTRESU"></a>LBSTRESU</td><td>Unit of the Standardized Result</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td><a href="#CL.UNIT">Unit</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBSPEC"></a>LBSPEC</td><td>Specimen Material Type</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">11</td><td><span class="linebreakcell"><a href="#CL.SPEC">Specimen</a></span><ul class="codelist"><li class="codelist-item">• "PLASMA"</li><li class="codelist-item">• "SERUM"</li><li class="codelist-item">• "URINE"</li><li class="codelist-item">• "WHOLE BLOOD"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBSPCCND"></a>LBSPCCND</td><td>Specimen Condition</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">18</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBLOC"></a>LBLOC</td><td>Specimen Collection Location</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBMETHOD"></a>LBMETHOD</td><td>Method of Test or Examination</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">77</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBBLFL"></a>LBBLFL</td><td>Baseline Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBUSCHFL"></a>LBUSCHFL</td><td>Unscheduled Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.VISITDY"></a>VISITDY</td><td>Planned Study Day of Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBDTC"></a>LBDTC</td><td>Date/Time of Specimen Collection</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBDY"></a>LBDY</td><td>Study Day of Specimen Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBNOMDY"></a>LBNOMDY</td><td>Nominal Study Day for Tabulations</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBNOMLBL"></a>LBNOMLBL</td><td>Label for Nominal Study Day</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">13</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Populated with the phase name and the planned date of data collection, in days from the phase start date.
</div></td></tr><tr class="tableroweven"><td><a id="IG.LB.IT.LB.LBTPT"></a>LBTPT</td><td>Planned Time Point Name</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.LB.IT.LB.LBTPTNUM"></a>LBTPTNUM</td><td>Planned Time Point Number</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TA"></a><div class="containerbox"><h1 class="invisible">Trial Arms (TA) </h1><table summary="ItemGroup IG.IG.TA"><caption><span>TA (Trial Arms) - TRIAL DESIGN <span class="dataset">Location: <a class="external" href="ta.xpt">ta.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.ARMCD"></a>ARMCD</td><td>Planned Arm Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.ARM"></a>ARM</td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.TAETORD"></a>TAETORD</td><td>Order of Element within Arm</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TA.IT.TA.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">36</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TA.IT.TA.EPOCH"></a>EPOCH</td><td>Trial Epoch</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TE"></a><div class="containerbox"><h1 class="invisible">Trial Elements (TE) </h1><table summary="ItemGroup IG.IG.TE"><caption><span>TE (Trial Elements) - TRIAL DESIGN <span class="dataset">Location: <a class="external" href="te.xpt">te.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.DOMAIN"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.ETCD"></a>ETCD</td><td>Element Code</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.ELEMENT"></a>ELEMENT</td><td>Description of Element</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">36</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.TESTRL"></a>TESTRL</td><td>Rule for Start of Element</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">19</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TE.IT.TE.TEENRL"></a>TEENRL</td><td>Rule for End of Element</td><td class="datatype">text</td><td class="role">Rule</td><td class="number">31</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TE.IT.TE.TEDUR"></a>TEDUR</td><td>Planned Duration of Element</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">4</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TX"></a><div class="containerbox"><h1 class="invisible">Trial Sets (TX) </h1><table summary="ItemGroup IG.IG.TX"><caption><span>TX (Trial Sets) - TRIAL DESIGN <span class="dataset">Location: <a class="external" href="tx.xpt">tx.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TX.IT.TX.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TX.IT.TX.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TX.IT.TX.SETCD"></a>SETCD</td><td></td><td>Set Code</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TX.IT.TX.SET"></a>SET</td><td></td><td>Set Description</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">4</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TX.IT.TX.TXSEQ"></a>TXSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TX.IT.TX.TXPARMCD"></a>TXPARMCD</td><td></td><td>Trial Set Parameter Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><a href="#CL.STSPRMCD">SEND Trial Summary Parameter Test Code</a><p class="linebreakcell">
                  [38 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TX.IT.TX.TXPARM"></a>TXPARM</td><td></td><td>Trial Set Parameter</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">33</td><td><a href="#CL.STSPRM">SEND Trial Summary Parameter Test Name</a><p class="linebreakcell">
                  [38 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>TXVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.TX.IT.TX.TXVAL">VLM</a></span></td><td></td><td>Trial Set Parameter Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">36</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.TX.IT.TX.TXVAL"><td></td><td><a href="#IG.TX.IT.TX.TXPARMCD" title="Trial Set Parameter Short Name">TXPARMCD</a> = "SPGRPCD" (Alpha-numeric character(s) assigned by the sponsor to identify a particular collection of subjects possessing common characteristic(s).)</td><td>SPGRPCD</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.TX.IT.TX.TXVAL"><td></td><td><a href="#IG.TX.IT.TX.TXPARMCD" title="Trial Set Parameter Short Name">TXPARMCD</a> = "GRPLBL" (Alpha-numeric character(s) assigned to identify a particular collection of subjects possessing common characteristic(s).)</td><td>GRPLBL</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.TS"></a><div class="containerbox"><h1 class="invisible">Trial Summary (TS) </h1><table summary="ItemGroup IG.IG.TS"><caption><span>TS (Trial Summary) - TRIAL DESIGN <span class="dataset">Location: <a class="external" href="ts.xpt">ts.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr class="header"><th scope="col">Variable</th><th scope="col">Where Condition</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.STUDYID"></a>STUDYID</td><td></td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.DOMAIN"></a>DOMAIN</td><td></td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSSEQ"></a>TSSEQ</td><td></td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSGRPID"></a>TSGRPID</td><td></td><td>Group Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.TS.IT.TS.TSPARMCD"></a>TSPARMCD</td><td></td><td>Trial Summary Parameter Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><a href="#CL.STSPRMCD">SEND Trial Summary Parameter Test Code</a><p class="linebreakcell">
                  [38 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSPARM"></a>TSPARM</td><td></td><td>Trial Summary Parameter</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">37</td><td><a href="#CL.STSPRM">SEND Trial Summary Parameter Test Name</a><p class="linebreakcell">
                  [38 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td>TSVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.TS.IT.TS.TSVAL">VLM</a></span></td><td></td><td>Parameter Value</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">96</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "STITLE" (The name of a nonclinical study.)</td><td>STITLE</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TRT" (The investigational product under study.)</td><td>TRT</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "AGEU" (Those units of time that are routinely used to express the age of a person. (NCI))</td><td>AGEU</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.AGEU">Age Unit</a></span><ul class="codelist"><li class="codelist-item">• "YEARS"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SDESIGN" (A plan detailing how a trial or study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and defining the methods of data analysis. Study design is driven by the research hypothesis being posed, study subject/population/sample available, logistics/resources: technology, support, networking, collaborative support, etc.)</td><td>SDESIGN</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.DESIGN">Study Design</a></span><ul class="codelist"><li class="codelist-item">• "PARALLEL"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "ROUTE" (The course by which a substance is administered in order to reach the site of action in the body.)</td><td>ROUTE</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.ROUTE">Route of Administration Response</a></span><ul class="codelist"><li class="codelist-item">• "INTRAMUSCULAR"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SNDIGVER" (The version of the Standard for the Exchange of Nonclinical Data Implementation Guide that is being used in the study submission.)</td><td>SNDIGVER</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.SNDIGVER">SEND Implementation Guide Version</a></span><ul class="codelist"><li class="codelist-item">• "SEND IMPLEMENTATION GUIDE VERSION 3.1"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SPECIES" (The common name for an animal used as the test system on a study (e.g., dog, monkey, mouse, rabbit, rat).)</td><td>SPECIES</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.SPECIES">Species</a></span><ul class="codelist"><li class="codelist-item">• "MONKEY"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SSTYP" (The type of nonclinical study performed e.g. Single Dose, Repeat Dose. (NCI))</td><td>SSTYP</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.SSTYP">SEND Study Type</a></span><ul class="codelist"><li class="codelist-item">• "REPEAT DOSE TOXICITY"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "STCAT" (The classification of the study. (NCI))</td><td>STCAT</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.STCAT">Study Category</a></span><ul class="codelist"><li class="codelist-item">• "TOX"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "STRAIN" (The vendor-supplied species/strain/substrain designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g. FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS and CHIMPANZEE).)</td><td>STRAIN</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.STRAIN">Strain/Substrain</a></span><ul class="codelist"><li class="codelist-item">• "CYNOMOLGUS"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "TFCNTRY" (The country of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA))</td><td>TFCNTRY</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.COUNTRY">Country</a></span><ul class="codelist"><li class="codelist-item">• "USA"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tablerowodd IG.TS.IT.TS.TSVAL"><td></td><td><a href="#IG.TS.IT.TS.TSPARMCD" title="Trial Summary Parameter Short Name">TSPARMCD</a> = "SEXPOP" (The specific sex, either male, female, or mixed of the subject group being studied. (NCI))</td><td>SEXPOP</td><td class="datatype">text</td><td class="role"></td><td class="number">200</td><td><span class="linebreakcell"><a href="#CL.SEXPOP">Sex of Participants Response</a></span><ul class="codelist"><li class="codelist-item">• "F" = "A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI)"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.TS.IT.TS.TSVALNF"></a>TSVALNF</td><td></td><td>Parameter Null Flavor</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">14</td><td><span class="linebreakcell"><a href="#CL.NULLFLAV">Null Flavor Reason</a></span><ul class="codelist"><li class="codelist-item">• "MASKED"</li><li class="codelist-item">• "NOT APPLICABLE"</li><li class="codelist-item">• "UNKNOWN"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPBW"></a><div class="containerbox"><h1 class="invisible">Supplemental Body Weight (SUPPBW) </h1><table summary="ItemGroup IG.IG.SUPPBW"><caption><span>SUPPBW (Supplemental Body Weight, Body Weight) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="suppbw.xpt">suppbw.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.BW">BW</a> (Body Weight)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPBW.IT.SUPPBW.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBW.IT.SUPPBW.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBW.IT.SUPPBW.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBW.IT.SUPPBW.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBW.IT.SUPPBW.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">2</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBW.IT.SUPPBW.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBW.IT.SUPPBW.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPBW.IT.SUPPBW.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPBW.IT.SUPPBW.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPBW.IT.SUPPBW.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSENAME"</div></td><td>PHSENAME</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPBW.IT.SUPPBW.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPBW.IT.SUPPBW.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHASEDAY"</div></td><td>PHASEDAY</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBW.IT.SUPPBW.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPBG"></a><div class="containerbox"><h1 class="invisible">Supplemental Body Weight Gain (SUPPBG) </h1><table summary="ItemGroup IG.IG.SUPPBG"><caption><span>SUPPBG (Supplemental Body Weight Gain, Body Weight Gains) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="suppbg.xpt">suppbg.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.BG">BG</a> (Body Weight Gains)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPBG.IT.SUPPBG.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBG.IT.SUPPBG.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBG.IT.SUPPBG.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBG.IT.SUPPBG.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBG.IT.SUPPBG.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">2</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPBG.IT.SUPPBG.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBG.IT.SUPPBG.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">18</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPBG.IT.SUPPBG.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPBG.IT.SUPPBG.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPBG.IT.SUPPBG.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSNAME2"</div></td><td>PHSNAME2</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPBG.IT.SUPPBG.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPBG.IT.SUPPBG.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSEDAY2"</div></td><td>PHSEDAY2</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPBG.IT.SUPPBG.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPCL"></a><div class="containerbox"><h1 class="invisible">Supplemental Clinical Observations (SUPPCL) </h1><table summary="ItemGroup IG.IG.SUPPCL"><caption><span>SUPPCL (Supplemental Clinical Observations, Clinical Observations) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="suppcl.xpt">suppcl.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.CL">CL</a> (Clinical Observations)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPCL.IT.SUPPCL.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPCL.IT.SUPPCL.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPCL.IT.SUPPCL.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPCL.IT.SUPPCL.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPCL.IT.SUPPCL.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">2</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPCL.IT.SUPPCL.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPCL.IT.SUPPCL.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPCL.IT.SUPPCL.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPCL.IT.SUPPCL.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPCL.IT.SUPPCL.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSENAME"</div></td><td>PHSENAME</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPCL.IT.SUPPCL.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPCL.IT.SUPPCL.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHASEDAY"</div></td><td>PHASEDAY</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPCL.IT.SUPPCL.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPDS"></a><div class="containerbox"><h1 class="invisible">Supplemental Disposition (SUPPDS) </h1><table summary="ItemGroup IG.IG.SUPPDS"><caption><span>SUPPDS (Supplemental Disposition, Disposition) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="suppds.xpt">suppds.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.DS">DS</a> (Disposition)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPDS.IT.SUPPDS.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDS.IT.SUPPDS.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDS.IT.SUPPDS.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDS.IT.SUPPDS.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDS.IT.SUPPDS.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPDS.IT.SUPPDS.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDS.IT.SUPPDS.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPDS.IT.SUPPDS.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">6</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPDS.IT.SUPPDS.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDS.IT.SUPPDS.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSENAME"</div></td><td>PHSENAME</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPDS.IT.SUPPDS.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPDS.IT.SUPPDS.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHASEDAY"</div></td><td>PHASEDAY</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPDS.IT.SUPPDS.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.SUPPLB"></a><div class="containerbox"><h1 class="invisible">Supplemental Laboratory Test Results (SUPPLB) </h1><table summary="ItemGroup IG.IG.SUPPLB"><caption><span>SUPPLB (Supplemental Laboratory Test Results, Laboratory) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="supplb.xpt">supplb.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.LB">LB</a> (Laboratory)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.SUPPLB.IT.SUPPLB.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPLB.IT.SUPPLB.RDOMAIN"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPLB.IT.SUPPLB.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPLB.IT.SUPPLB.IDVAR"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPLB.IT.SUPPLB.IDVARVAL"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.SUPPLB.IT.SUPPLB.QNAM"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPLB.IT.SUPPLB.QLABEL"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.SUPPLB.IT.SUPPLB.QVAL">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPLB.IT.SUPPLB.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPLB.IT.SUPPLB.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHSENAME"</div></td><td>PHSENAME</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.SUPPLB.IT.SUPPLB.QVAL"><td><div class="qval-indent">➤  <a href="#IG.SUPPLB.IT.SUPPLB.QNAM" title="Qualifier Variable Name">QNAM</a> = "PHASEDAY"</div></td><td>PHASEDAY</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.SUPPLB.IT.SUPPLB.QORIG"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.8d086f3d-854e-4e50"></a><div class="containerbox"><h1 class="invisible">Immunogenicity Specimen Assessments (IS) </h1><table summary="ItemGroup IG.IG.8d086f3d-854e-4e50"><caption><span>IS (Immunogenicity Specimen Assessments) - FINDINGS <span class="dataset">Location: <a class="external" href="is.xpt">is.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Supplemental Qualifiers Dataset: <a href="#IG.IG.71c8c332-b176-474b">SUPPIS</a> (Supplemental Immunogenicity Specimen)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.15cee1a5-8cff-4a7a"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.0c98cb6b-8b3f-4034"></a>DOMAIN</td><td>Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.cd75dada-a378-4f77"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.cbd1625e-8cd5-498f"></a>ISSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.39ded562-a2b9-4838"></a>ISTESTCD</td><td>Immunogenicity Test/Exam Short Name</td><td class="datatype">text</td><td class="role">Topic</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.86d1da8a-8d6c-4216">ISTESTCD</a></span><ul class="codelist"><li class="codelist-item">• "IGMHBA" = "Hepatitis B Vaccine (HBsAg) IgM Serum Analysis"</li><li class="codelist-item">• "IGGHBA" = "Hepatitis B Vaccine (HBsAg) IgG Serum Analysis"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.040d34e3-88cf-43ab"></a>ISTEST</td><td>Immunogenicity Test or Examination Name</td><td class="datatype">text</td><td class="role">Synonym Qualifier</td><td class="number">39</td><td><span class="linebreakcell"><a href="#CL.CL.fe7e121a-b0cc-4796">ISTEST</a></span><ul class="codelist"><li class="codelist-item">• "HBsAg IgM"</li><li class="codelist-item">• "HBsAg IgG"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.73b62958-9ea2-4973"></a>ISCAT</td><td>Category for Immunogenicity Test</td><td class="datatype">text</td><td class="role">Grouping Qualifier</td><td class="number">26</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.1a5a0a85-9bcb-4fc2"></a>ISORRES</td><td>Result or Findings as Collected</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.e3bde74c-9d92-40c9"></a>ISORRESU</td><td>Original Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.3aef2728-a896-49f6"></a>ISSTRESC</td><td>Standardized Result in Character Format</td><td class="datatype">text</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.99360fa4-a3ea-4b62"></a>ISSTRESN</td><td>Standardized Result in Numeric Format</td><td class="datatype">float</td><td class="role">Result Qualifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.46b8e75f-ab82-4570"></a>ISSTRESU</td><td>Standard Units</td><td class="datatype">text</td><td class="role">Variable Qualifier</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.d2fca64d-a119-4bce">IS.UNIT</a></span><ul class="codelist"><li class="codelist-item">• "U/mL"</li></ul></td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.a18dd54c-a3c0-40f2"></a>ISSPEC</td><td>Specimen Material Type</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">11</td><td><span class="linebreakcell"><a href="#CL.SPEC">Specimen</a></span><ul class="codelist"><li class="codelist-item">• "PLASMA"</li><li class="codelist-item">• "SERUM"</li><li class="codelist-item">• "URINE"</li><li class="codelist-item">• "WHOLE BLOOD"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.cf62f2a4-89c6-4ba5"></a>ISLOC</td><td>Specimen Collection Location</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.174ef05c-aa63-45a7"></a>ISMETHOD</td><td>Method of Test or Examination</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">77</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.c9011a24-8a9e-4d28"></a>ISBLFL</td><td>Baseline Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Last non-null predose observation per subject per test</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.ec0cdd96-ae0d-45b8"></a>ISFAST</td><td>Fasting Status</td><td class="datatype">text</td><td class="role"></td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.dfba3bc2-8b0e-4e5b"></a>ISLLOQ</td><td>Lower Limit of Quantitation</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.9cdda736-ab09-4fb0"></a>ISUSCHFL</td><td>Unscheduled Flag</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.NY">No Yes Response</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.1a244dec-96e1-41bd"></a>ISDTC</td><td>Date/Time of Specimen Collection</td><td class="datatype">datetime</td><td class="role">Timing</td><td class="number"></td><td>ISO 8601</td><td><div class="linebreakcell">COLLECTED</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.71fdb632-bc90-4756"></a>ISDY</td><td>Study Day of Specimen Collection</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr class="tableroweven"><td><a id="IG.8d086f3d-854e-4e50.IT.c6766d44-8996-44be"></a>ISNOMDY</td><td>Nominal Study Day for Tabulations</td><td class="datatype">integer</td><td class="role">Timing</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr class="tablerowodd"><td><a id="IG.8d086f3d-854e-4e50.IT.932d65d0-9535-48de"></a>ISNOMLBL</td><td>Label for Nominal Study Day</td><td class="datatype">text</td><td class="role">Timing</td><td class="number">13</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Populated with the phase name and the planned date of data collection, in days from the phase start date.
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.71c8c332-b176-474b"></a><div class="containerbox"><h1 class="invisible">Supplemental Immunogenicity Specimen (SUPPIS) </h1><table summary="ItemGroup IG.IG.71c8c332-b176-474b"><caption><span>SUPPIS (Supplemental Immunogenicity Specimen, Immunogenicity Specimen Assessments) - RELATIONSHIP <span class="dataset">Location: <a class="external" href="suppis.xpt">suppis.xpt</a><span class="external-link-gif"></span> </span></span></caption><tr><td colspan="8">Related Parent Dataset: <a href="#IG.IG.8d086f3d-854e-4e50">IS</a> (Immunogenicity Specimen Assessments)</td></tr><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col">Role</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.71c8c332-b176-474b.IT.72a7a54e-9c53-4d2c"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.71c8c332-b176-474b.IT.52977f39-aff3-49cc"></a>RDOMAIN</td><td>Related Domain Abbreviation</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">2</td><td><a href="#CL.SDOMAIN">SEND Domain Abbreviation</a><p class="linebreakcell">
                  [14 Terms]
                </p></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.71c8c332-b176-474b.IT.cc4c63b6-8d1a-404e"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">14</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.71c8c332-b176-474b.IT.c113593a-90c0-49ed"></a>IDVAR</td><td>Identifying Variable</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">5</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.71c8c332-b176-474b.IT.2b11089a-9180-49f2"></a>IDVARVAL</td><td>Identifying Variable Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">2</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td><a id="IG.71c8c332-b176-474b.IT.bfb4fc85-b376-424e"></a>QNAM</td><td>Qualifier Variable Name</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">8</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.71c8c332-b176-474b.IT.78c66954-a8e6-4e07"></a>QLABEL</td><td>Qualifier Variable Label</td><td class="datatype">text</td><td class="role">Identifier</td><td class="number">12</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tableroweven"><td>QVAL<span class="valuelist-reference" onclick="toggle_vlm(this);"><a id="IG.71c8c332-b176-474b.IT.a7c4ce4e-aef6-460d">VLM</a></span></td><td>Data Value</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">7</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.71c8c332-b176-474b.IT.a7c4ce4e-aef6-460d"><td><div class="qval-indent">➤  <a href="#IG.71c8c332-b176-474b.IT.bfb4fc85-b376-424e" title="Qualifier Variable Name">QNAM</a> = "PHSENAME"</div></td><td>PHSENAME</td><td class="datatype">text</td><td class="role"></td><td class="number">64</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="vlm tableroweven IG.71c8c332-b176-474b.IT.a7c4ce4e-aef6-460d"><td><div class="qval-indent">➤  <a href="#IG.71c8c332-b176-474b.IT.bfb4fc85-b376-424e" title="Qualifier Variable Name">QNAM</a> = "PHASEDAY"</div></td><td>PHASEDAY</td><td class="datatype">integer</td><td class="role"></td><td class="number">3</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr><tr class="tablerowodd"><td><a id="IG.71c8c332-b176-474b.IT.0d30256e-a3b1-40c0"></a>QORIG</td><td>Origin</td><td class="datatype">text</td><td class="role">Record Qualifier</td><td class="number">9</td><td></td><td><div class="linebreakcell">OTHER</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="decodelist"></a><div class="containerbox"><h1 class="header">CodeLists</h1><div class="codelist" id="CL.AGEU"><div class="codelist-caption">Age Unit [<span class="nci">C66781</span>]</div><table summary="Code List - Age Unit"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>YEARS [<span class="nci">C29848</span>]</td></tr></table></div><div class="codelist" id="CL.BGTEST"><div class="codelist-caption">Body Weight Gain Test Name [<span class="nci">C89959</span>]</div><table summary="Code List - Body Weight Gain Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Body Weight Gain [<span class="nci">C62754</span>]</td></tr></table></div><div class="codelist" id="CL.BGTESTCD"><div class="codelist-caption">Body Weight Gain Test Code [<span class="nci">C89960</span>]</div><table summary="Controlled Term - Body Weight Gain Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>BWGAIN [<span class="nci">C62754</span>]</td><td class="codelist-item-decode">A change in overall body weight, relative to the beginning of the collection period.</td></tr></table></div><div class="codelist" id="CL.BWTEST"><div class="codelist-caption">Body Weight Test Name [<span class="nci">C89961</span>]</div><table summary="Code List - Body Weight Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Body Weight [<span class="nci">C81328</span>]</td></tr></table></div><div class="codelist" id="CL.BWTESTCD"><div class="codelist-caption">Body Weight Test Code [<span class="nci">C89962</span>]</div><table summary="Controlled Term - Body Weight Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>BW [<span class="nci">C81328</span>]</td><td class="codelist-item-decode">The weight of a subject. (NCI)</td></tr></table></div><div class="codelist" id="CL.CLCAT"><div class="codelist-caption">Category for Clinical Observation [<span class="nci">C89963</span>]</div><table summary="Code List - Category for Clinical Observation"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>CLINICAL SIGNS [<span class="nci">C100104</span>]</td></tr></table></div><div class="codelist" id="CL.CLSCAT"><div class="codelist-caption">CLSCAT</div><table summary="Code List - CLSCAT"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Discharge [<span class="extended">*</span>]</td></tr><tr class="tableroweven"><td>Excretion [<span class="extended">*</span>]</td></tr><tr class="tablerowodd"><td>Physical Appearance [<span class="extended">*</span>]</td></tr><tr class="tableroweven"><td>Vet Exam [<span class="extended">*</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CLTEST"><div class="codelist-caption">CLTEST</div><table summary="Code List - CLTEST"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Clinical Observation [<span class="extended">*</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.CLTESTCD"><div class="codelist-caption">CLTESTCD</div><table summary="Controlled Term - CLTESTCD"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CLNOB [<span class="extended">*</span>]</td><td class="codelist-item-decode">An assessment of clinical observations.</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.COUNTRY"><div class="codelist-caption">Country [<span class="nci">C66786</span>]</div><table summary="Code List - Country"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>USA [<span class="nci">C17234</span>]</td></tr></table></div><div class="codelist" id="CL.DESIGN"><div class="codelist-caption">Study Design [<span class="nci">C89967</span>]</div><table summary="Code List - Study Design"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>PARALLEL [<span class="nci">C82639</span>]</td></tr></table></div><div class="codelist" id="CL.DSDECOD"><div class="codelist-caption">Standardized Disposition Term [<span class="nci">C89968</span>]</div><table summary="Code List - Standardized Disposition Term"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>REMOVED FROM STUDY ALIVE [<span class="nci">C90447</span>]</td></tr></table></div><div class="codelist" id="CL.FREQ"><div class="codelist-caption">Frequency [<span class="nci">C71113</span>]</div><table summary="Code List - Frequency"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>TWICE [<span class="nci">C65134</span>]</td></tr></table></div><div class="codelist" id="CL.FRM"><div class="codelist-caption">Pharmaceutical Dosage Form [<span class="nci">C66726</span>]</div><table summary="Code List - Pharmaceutical Dosage Form"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SOLUTION [<span class="nci">C42986</span>]</td></tr></table></div><div class="codelist" id="CL.LBCAT"><div class="codelist-caption">LBCAT</div><table summary="Code List - LBCAT"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>CLINICAL CHEMISTRY [<span class="extended">*</span>]</td></tr><tr class="tableroweven"><td>COAGULATION [<span class="extended">*</span>]</td></tr><tr class="tablerowodd"><td>HEMATOLOGY [<span class="extended">*</span>]</td></tr><tr class="tableroweven"><td>URINALYSIS/URINE CHEMISTRY [<span class="extended">*</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.LBTEST"><div class="codelist-caption">Laboratory Test Name [<span class="nci">C67154</span>]</div><table summary="Code List - Laboratory Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Activated Partial Thromboplastin Time [<span class="nci">C38462</span>]</td></tr><tr class="tableroweven"><td>Alanine Aminotransferase [<span class="nci">C64433</span>]</td></tr><tr class="tablerowodd"><td>Albumin [<span class="nci">C64431</span>]</td></tr><tr class="tableroweven"><td>Albumin/Globulin [<span class="nci">C74894</span>]</td></tr><tr class="tablerowodd"><td>Alkaline Phosphatase [<span class="nci">C64432</span>]</td></tr><tr class="tableroweven"><td>Anisocytes [<span class="nci">C74797</span>]</td></tr><tr class="tablerowodd"><td>Aspartate Aminotransferase [<span class="nci">C64467</span>]</td></tr><tr class="tableroweven"><td>Bacteria [<span class="nci">C64469</span>]</td></tr><tr class="tablerowodd"><td>Basophils [<span class="nci">C64470</span>]</td></tr><tr class="tableroweven"><td>Basophils/Leukocytes [<span class="nci">C64471</span>]</td></tr><tr class="tablerowodd"><td>Bilirubin [<span class="nci">C38037</span>]</td></tr><tr class="tableroweven"><td>Calcium [<span class="nci">C64488</span>]</td></tr><tr class="tablerowodd"><td>Casts [<span class="nci">C74763</span>]</td></tr><tr class="tableroweven"><td>Chloride [<span class="nci">C64495</span>]</td></tr><tr class="tablerowodd"><td>Cholesterol [<span class="nci">C105586</span>]</td></tr><tr class="tableroweven"><td>Clarity [<span class="nci">C96594</span>]</td></tr><tr class="tablerowodd"><td>Color [<span class="nci">C64546</span>]</td></tr><tr class="tableroweven"><td>Creatine Kinase [<span class="nci">C64489</span>]</td></tr><tr class="tablerowodd"><td>Creatinine [<span class="nci">C64547</span>]</td></tr><tr class="tableroweven"><td>Crystals [<span class="nci">C74673</span>]</td></tr><tr class="tablerowodd"><td>Direct Bilirubin [<span class="nci">C64481</span>]</td></tr><tr class="tableroweven"><td>Eosinophils [<span class="nci">C64550</span>]</td></tr><tr class="tablerowodd"><td>Eosinophils/Leukocytes [<span class="nci">C64604</span>]</td></tr><tr class="tableroweven"><td>Epithelial Cells [<span class="nci">C64605</span>]</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular HGB Concentration [<span class="nci">C64798</span>]</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Hemoglobin [<span class="nci">C64797</span>]</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Volume [<span class="nci">C64799</span>]</td></tr><tr class="tableroweven"><td>Erythrocytes [<span class="nci">C51946</span>]</td></tr><tr class="tablerowodd"><td>Gamma Glutamyl Transferase [<span class="nci">C64847</span>]</td></tr><tr class="tableroweven"><td>Globulin [<span class="nci">C74738</span>]</td></tr><tr class="tablerowodd"><td>Glucose [<span class="nci">C105585</span>]</td></tr><tr class="tableroweven"><td>Hematocrit [<span class="nci">C64796</span>]</td></tr><tr class="tablerowodd"><td>Hemoglobin [<span class="nci">C64848</span>]</td></tr><tr class="tableroweven"><td>Hypochromia [<span class="nci">C64802</span>]</td></tr><tr class="tablerowodd"><td>Ketones [<span class="nci">C64854</span>]</td></tr><tr class="tableroweven"><td>Large Unstained Cells [<span class="nci">C74659</span>]</td></tr><tr class="tablerowodd"><td>Large Unstained Cells/Leukocytes [<span class="nci">C79467</span>]</td></tr><tr class="tableroweven"><td>Leukocytes [<span class="nci">C51948</span>]</td></tr><tr class="tablerowodd"><td>Lymphocytes [<span class="nci">C51949</span>]</td></tr><tr class="tableroweven"><td>Lymphocytes/Leukocytes [<span class="nci">C64820</span>]</td></tr><tr class="tablerowodd"><td>Monocytes [<span class="nci">C64823</span>]</td></tr><tr class="tableroweven"><td>Monocytes/Leukocytes [<span class="nci">C64824</span>]</td></tr><tr class="tablerowodd"><td>Neutrophils [<span class="nci">C63321</span>]</td></tr><tr class="tableroweven"><td>Neutrophils/Leukocytes [<span class="nci">C64827</span>]</td></tr><tr class="tablerowodd"><td>Occult Blood [<span class="nci">C74686</span>]</td></tr><tr class="tableroweven"><td>Other Urine Microscopic Findings [<span class="extended">*</span>]</td></tr><tr class="tablerowodd"><td>Phosphate [<span class="nci">C64857</span>]</td></tr><tr class="tableroweven"><td>Platelets [<span class="nci">C51951</span>]</td></tr><tr class="tablerowodd"><td>Poikilocytes [<span class="nci">C79602</span>]</td></tr><tr class="tableroweven"><td>Polychromasia [<span class="nci">C64803</span>]</td></tr><tr class="tablerowodd"><td>Potassium [<span class="nci">C64853</span>]</td></tr><tr class="tableroweven"><td>Protein [<span class="nci">C64858</span>]</td></tr><tr class="tablerowodd"><td>Prothrombin Time [<span class="nci">C62656</span>]</td></tr><tr class="tableroweven"><td>Reticulocytes [<span class="nci">C51947</span>]</td></tr><tr class="tablerowodd"><td>Reticulocytes/Erythrocytes [<span class="nci">C64828</span>]</td></tr><tr class="tableroweven"><td>Sodium [<span class="nci">C64809</span>]</td></tr><tr class="tablerowodd"><td>Specific Gravity [<span class="nci">C64832</span>]</td></tr><tr class="tableroweven"><td>Toxic Granulation [<span class="nci">C96641</span>]</td></tr><tr class="tablerowodd"><td>Triglycerides [<span class="nci">C64812</span>]</td></tr><tr class="tableroweven"><td>Unclassified Casts [<span class="nci">C74776</span>]</td></tr><tr class="tablerowodd"><td>Unclassified Crystals [<span class="nci">C74757</span>]</td></tr><tr class="tableroweven"><td>Urea Nitrogen [<span class="nci">C125949</span>]</td></tr><tr class="tablerowodd"><td>Urobilinogen [<span class="nci">C64816</span>]</td></tr><tr class="tableroweven"><td>Volume [<span class="nci">C74720</span>]</td></tr><tr class="tablerowodd"><td>pH [<span class="nci">C45997</span>]</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.LBTESTCD"><div class="codelist-caption">Laboratory Test Code [<span class="nci">C65047</span>]</div><table summary="Controlled Term - Laboratory Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALB [<span class="nci">C64431</span>]</td><td class="codelist-item-decode">A measurement of the albumin protein in a biological specimen.</td></tr><tr class="tableroweven"><td>ALBGLOB [<span class="nci">C74894</span>]</td><td class="codelist-item-decode">The ratio of albumin to globulin in a biological specimen.</td></tr><tr class="tablerowodd"><td>ALP [<span class="nci">C64432</span>]</td><td class="codelist-item-decode">A measurement of the alkaline phosphatase in a biological specimen.</td></tr><tr class="tableroweven"><td>ALT [<span class="nci">C64433</span>]</td><td class="codelist-item-decode">A measurement of the alanine aminotransferase in a biological specimen.</td></tr><tr class="tablerowodd"><td>ANISO [<span class="nci">C74797</span>]</td><td class="codelist-item-decode">A measurement of the variability in the size of the red blood cells in a whole blood specimen.</td></tr><tr class="tableroweven"><td>APTT [<span class="nci">C38462</span>]</td><td class="codelist-item-decode">A measurement of the length of time that it takes for clotting to occur when reagents are added to a plasma specimen. The test is partial due to the absence of tissue factor (Factor III) from the reaction mixture.</td></tr><tr class="tablerowodd"><td>AST [<span class="nci">C64467</span>]</td><td class="codelist-item-decode">A measurement of the aspartate aminotransferase in a biological specimen.</td></tr><tr class="tableroweven"><td>BACT [<span class="nci">C64469</span>]</td><td class="codelist-item-decode">A measurement of the bacteria in a biological specimen.</td></tr><tr class="tablerowodd"><td>BASO [<span class="nci">C64470</span>]</td><td class="codelist-item-decode">A measurement of the basophils in a biological specimen.</td></tr><tr class="tableroweven"><td>BASOLE [<span class="nci">C64471</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of the basophils to leukocytes in a biological specimen.</td></tr><tr class="tablerowodd"><td>BILDIR [<span class="nci">C64481</span>]</td><td class="codelist-item-decode">A measurement of the conjugated or water-soluble bilirubin in a biological specimen.</td></tr><tr class="tableroweven"><td>BILI [<span class="nci">C38037</span>]</td><td class="codelist-item-decode">A measurement of the total bilirubin in a biological specimen.</td></tr><tr class="tablerowodd"><td>CA [<span class="nci">C64488</span>]</td><td class="codelist-item-decode">A measurement of the calcium in a biological specimen.</td></tr><tr class="tableroweven"><td>CASTS [<span class="nci">C74763</span>]</td><td class="codelist-item-decode">A statement that indicates casts were looked for in a biological specimen.</td></tr><tr class="tablerowodd"><td>CHOL [<span class="nci">C105586</span>]</td><td class="codelist-item-decode">A measurement of the cholesterol in a biological specimen.</td></tr><tr class="tableroweven"><td>CK [<span class="nci">C64489</span>]</td><td class="codelist-item-decode">A measurement of the total creatine kinase in a biological specimen.</td></tr><tr class="tablerowodd"><td>CL [<span class="nci">C64495</span>]</td><td class="codelist-item-decode">A measurement of the chloride in a biological specimen.</td></tr><tr class="tableroweven"><td>CLARITY [<span class="nci">C96594</span>]</td><td class="codelist-item-decode">A measurement of the transparency of a biological specimen.</td></tr><tr class="tablerowodd"><td>COLOR [<span class="nci">C64546</span>]</td><td class="codelist-item-decode">A measurement of the color of a biological specimen.</td></tr><tr class="tableroweven"><td>CREAT [<span class="nci">C64547</span>]</td><td class="codelist-item-decode">A measurement of the creatinine in a biological specimen.</td></tr><tr class="tablerowodd"><td>CRYSTALS [<span class="nci">C74673</span>]</td><td class="codelist-item-decode">A statement that indicates crystals were looked for in a biological specimen.</td></tr><tr class="tableroweven"><td>CSUNCLA [<span class="nci">C74776</span>]</td><td class="codelist-item-decode">A measurement of the unclassifiable casts present in a biological specimen.</td></tr><tr class="tablerowodd"><td>CYUNCLA [<span class="nci">C74757</span>]</td><td class="codelist-item-decode">A measurement of the unclassifiable crystals present in a biological specimen.</td></tr><tr class="tableroweven"><td>EOS [<span class="nci">C64550</span>]</td><td class="codelist-item-decode">A measurement of the eosinophils in a biological specimen.</td></tr><tr class="tablerowodd"><td>EOSLE [<span class="nci">C64604</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of the eosinophils to leukocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>EPIC [<span class="nci">C64605</span>]</td><td class="codelist-item-decode">A measurement of the epithelial cells in a biological specimen.</td></tr><tr class="tablerowodd"><td>GGT [<span class="nci">C64847</span>]</td><td class="codelist-item-decode">A measurement of the gamma glutamyl transferase in a biological specimen.</td></tr><tr class="tableroweven"><td>GLOBUL [<span class="nci">C74738</span>]</td><td class="codelist-item-decode">A measurement of the globulin protein in a biological specimen.</td></tr><tr class="tablerowodd"><td>GLUC [<span class="nci">C105585</span>]</td><td class="codelist-item-decode">A measurement of the glucose in a biological specimen.</td></tr><tr class="tableroweven"><td>HCT [<span class="nci">C64796</span>]</td><td class="codelist-item-decode">The percentage of a whole blood specimen that is composed of red blood cells (erythrocytes).</td></tr><tr class="tablerowodd"><td>HGB [<span class="nci">C64848</span>]</td><td class="codelist-item-decode">A measurement of the total erythrocyte associated hemoglobin in a biological specimen.</td></tr><tr class="tableroweven"><td>HPOCROM [<span class="nci">C64802</span>]</td><td class="codelist-item-decode">An observation which indicates that the hemoglobin concentration in a red blood cell specimen has fallen below a specified level.</td></tr><tr class="tablerowodd"><td>K [<span class="nci">C64853</span>]</td><td class="codelist-item-decode">A measurement of the potassium in a biological specimen.</td></tr><tr class="tableroweven"><td>KETONES [<span class="nci">C64854</span>]</td><td class="codelist-item-decode">A measurement of the ketones in a biological specimen.</td></tr><tr class="tablerowodd"><td>LGLUCLE [<span class="nci">C79467</span>]</td><td class="codelist-item-decode">A relative measure (ratio or percentage) of the large unstained cells to leukocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>LGUNSCE [<span class="nci">C74659</span>]</td><td class="codelist-item-decode">A measurement of the large, peroxidase-negative cells which cannot be further characterized (i.e. as large lymphocytes, virocytes, or stem cells) present in a biological specimen.</td></tr><tr class="tablerowodd"><td>LYM [<span class="nci">C51949</span>]</td><td class="codelist-item-decode">A measurement of the lymphocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>LYMLE [<span class="nci">C64820</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of the lymphocytes to leukocytes in a biological specimen.</td></tr><tr class="tablerowodd"><td>MCH [<span class="nci">C64797</span>]</td><td class="codelist-item-decode">A measurement of the mean amount of hemoglobin per erythrocyte in a biological specimen, calculated as the product of hemoglobin times ten, divided by the number of erythrocytes.</td></tr><tr class="tableroweven"><td>MCHC [<span class="nci">C64798</span>]</td><td class="codelist-item-decode">An indirect measurement of the average concentration of hemoglobin per erythrocyte in a biological specimen, calculated as the ratio of hemoglobin to hematocrit.</td></tr><tr class="tablerowodd"><td>MCV [<span class="nci">C64799</span>]</td><td class="codelist-item-decode">A measurement of the mean cellular volume per erythrocyte in a biological specimen.</td></tr><tr class="tableroweven"><td>MONO [<span class="nci">C64823</span>]</td><td class="codelist-item-decode">A measurement of the monocytes in a biological specimen.</td></tr><tr class="tablerowodd"><td>MONOLE [<span class="nci">C64824</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of the monocytes to leukocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>NEUT [<span class="nci">C63321</span>]</td><td class="codelist-item-decode">A measurement of the neutrophils in a biological specimen.</td></tr><tr class="tablerowodd"><td>NEUTLE [<span class="nci">C64827</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of the neutrophils to leukocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>OCCBLD [<span class="nci">C74686</span>]</td><td class="codelist-item-decode">A measurement of the blood in body products such as a urine or stool sample, not detectable on gross examination.</td></tr><tr class="tablerowodd"><td>OTHR [<span class="extended">*</span>]</td><td class="codelist-item-decode">Sperm was observed as present in the urine sample during a microscopic examination.</td></tr><tr class="tableroweven"><td>PH [<span class="nci">C45997</span>]</td><td class="codelist-item-decode">The negative logarithm (base 10) of the concentration of hydronium ions, which is used as a measure of the acidity or alkalinity of a fluid.</td></tr><tr class="tablerowodd"><td>PHOS [<span class="nci">C64857</span>]</td><td class="codelist-item-decode">A measurement of the phosphate in a biological specimen.</td></tr><tr class="tableroweven"><td>PLAT [<span class="nci">C51951</span>]</td><td class="codelist-item-decode">A measurement of the platelets (non-nucleated thrombocytes) in a biological specimen.</td></tr><tr class="tablerowodd"><td>POIKILO [<span class="nci">C79602</span>]</td><td class="codelist-item-decode">A measurement of the odd-shaped erythrocytes in a whole blood specimen.</td></tr><tr class="tableroweven"><td>POLYCHR [<span class="nci">C64803</span>]</td><td class="codelist-item-decode">A measurement of the blue-staining characteristic of newly generated erythrocytes.</td></tr><tr class="tablerowodd"><td>PROT [<span class="nci">C64858</span>]</td><td class="codelist-item-decode">A measurement of the total protein in a biological specimen.</td></tr><tr class="tableroweven"><td>PT [<span class="nci">C62656</span>]</td><td class="codelist-item-decode">A blood clotting measurement that evaluates the extrinsic pathway of coagulation.</td></tr><tr class="tablerowodd"><td>RBC [<span class="nci">C51946</span>]</td><td class="codelist-item-decode">A measurement of the total erythrocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>RETI [<span class="nci">C51947</span>]</td><td class="codelist-item-decode">A measurement of the reticulocytes in a biological specimen.</td></tr><tr class="tablerowodd"><td>RETIRBC [<span class="nci">C64828</span>]</td><td class="codelist-item-decode">A relative measurement (ratio or percentage) of reticulocytes to erythrocytes in a biological specimen.</td></tr><tr class="tableroweven"><td>SODIUM [<span class="nci">C64809</span>]</td><td class="codelist-item-decode">A measurement of the sodium in a biological specimen.</td></tr><tr class="tablerowodd"><td>SPGRAV [<span class="nci">C64832</span>]</td><td class="codelist-item-decode">A ratio of the density of a fluid to the density of water.</td></tr><tr class="tableroweven"><td>TOXGRAN [<span class="nci">C96641</span>]</td><td class="codelist-item-decode">A measurement of the toxic granulation in granulocytic blood cells.</td></tr><tr class="tablerowodd"><td>TRIG [<span class="nci">C64812</span>]</td><td class="codelist-item-decode">A measurement of the triglycerides in a biological specimen.</td></tr><tr class="tableroweven"><td>UREAN [<span class="nci">C125949</span>]</td><td class="codelist-item-decode">A measurement of the urea nitrogen in a biological specimen.</td></tr><tr class="tablerowodd"><td>UROBIL [<span class="nci">C64816</span>]</td><td class="codelist-item-decode">A measurement of the urobilinogen in a biological specimen.</td></tr><tr class="tableroweven"><td>VOLUME [<span class="nci">C74720</span>]</td><td class="codelist-item-decode">A measurement of the volume of a biological specimen.</td></tr><tr class="tablerowodd"><td>WBC [<span class="nci">C51948</span>]</td><td class="codelist-item-decode">A measurement of the leukocytes in a biological specimen.</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.NULLFLAV"><div class="codelist-caption">Null Flavor Reason [<span class="nci">C150810</span>]</div><table summary="Code List - Null Flavor Reason"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>MASKED [<span class="nci">C150904</span>]</td></tr><tr class="tableroweven"><td>NOT APPLICABLE [<span class="nci">C48660</span>]</td></tr><tr class="tablerowodd"><td>UNKNOWN [<span class="nci">C17998</span>]</td></tr></table></div><div class="codelist" id="CL.NY"><div class="codelist-caption">No Yes Response [<span class="nci">C66742</span>]</div><table summary="Controlled Term - No Yes Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Y [<span class="nci">C49488</span>] [<span class="extended">*</span>]</td><td class="codelist-item-decode">Yes</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.ROUTE"><div class="codelist-caption">Route of Administration Response [<span class="nci">C66729</span>]</div><table summary="Code List - Route of Administration Response"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>INTRAMUSCULAR [<span class="nci">C28161</span>]</td></tr></table></div><div class="codelist" id="CL.SDOMAIN"><div class="codelist-caption">SEND Domain Abbreviation [<span class="nci">C111113</span>]</div><table summary="Controlled Term - SEND Domain Abbreviation"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>BG [<span class="nci">C95083</span>]</td><td class="codelist-item-decode">Body weight gain is the actual difference between two body weight measurements for any given interval for a subject. This is most commonly shown as the difference between two consecutive body weight measurements.</td></tr><tr class="tableroweven"><td>BW [<span class="nci">C95085</span>]</td><td class="codelist-item-decode">This domain captures body weights collected for subjects during the study and at the end of the study (terminal body weights).</td></tr><tr class="tablerowodd"><td>CL [<span class="nci">C95086</span>]</td><td class="codelist-item-decode">This domain captures clinical sign information including ophthalmology, physical examination, and dermal examination collected in life while executing the study.</td></tr><tr class="tableroweven"><td>CO [<span class="nci">C49569</span>]</td><td class="codelist-item-decode">A special-purpose domain that contains comments that may be collected alongside other data.</td></tr><tr class="tablerowodd"><td>DM [<span class="nci">C49572</span>]</td><td class="codelist-item-decode">A special-purpose domain that includes a set of essential standard variables that describe each subject in a clinical study. It is the parent domain for all other observations for human clinical subjects.</td></tr><tr class="tableroweven"><td>DS [<span class="nci">C49576</span>]</td><td class="codelist-item-decode">An events domain that contains information encompassing and representing data related to subject disposition.</td></tr><tr class="tablerowodd"><td>EX [<span class="nci">C49587</span>]</td><td class="codelist-item-decode">An interventions domain that contains the details of a subject's exposure to protocol-specified study treatment. Study treatment may be any intervention that is prospectively defined as a test material within a study, and is typically but not always supplied to the subject.</td></tr><tr class="tableroweven"><td>LB [<span class="nci">C49592</span>]</td><td class="codelist-item-decode">A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains.</td></tr><tr class="tablerowodd"><td>SE [<span class="nci">C49616</span>]</td><td class="codelist-item-decode">A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element.</td></tr><tr class="tableroweven"><td>TA [<span class="nci">C49618</span>]</td><td class="codelist-item-decode">A trial design domain that contains each planned arm in the trial.</td></tr><tr class="tablerowodd"><td>TE [<span class="nci">C49619</span>]</td><td class="codelist-item-decode">A trial design domain that contains the element code that is unique for each element, the element description, and the rules for starting and ending an element.</td></tr><tr class="tableroweven"><td>TS [<span class="nci">C53483</span>]</td><td class="codelist-item-decode">A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented.</td></tr><tr class="tablerowodd"><td>TX [<span class="nci">C95103</span>]</td><td class="codelist-item-decode">A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. This domain is not subject oriented.</td></tr><tr class="tableroweven"><td>IS [<span class="extended">*</span>]</td><td class="codelist-item-decode">A findings domain for assessments that determine whether a therapy induced an immune response.</td></tr></table><p class="footnote"><span class="super">*</span> Extended Value</p></div><div class="codelist" id="CL.SEX"><div class="codelist-caption">Sex [<span class="nci">C66731</span>]</div><table summary="Controlled Term - Sex"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>F [<span class="nci">C16576</span>]</td><td class="codelist-item-decode">A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI)</td></tr></table></div><div class="codelist" id="CL.SEXPOP"><div class="codelist-caption">Sex of Participants Response [<span class="nci">C66732</span>]</div><table summary="Controlled Term - Sex of Participants Response"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>F [<span class="nci">C16576</span>]</td><td class="codelist-item-decode">A person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI)</td></tr></table></div><div class="codelist" id="CL.SNDIGVER"><div class="codelist-caption">SEND Implementation Guide Version [<span class="nci">C89982</span>]</div><table summary="Code List - SEND Implementation Guide Version"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>SEND IMPLEMENTATION GUIDE VERSION 3.1 [<span class="nci">C120925</span>]</td></tr></table></div><div class="codelist" id="CL.SPEC"><div class="codelist-caption">Specimen [<span class="nci">C77529</span>]</div><table summary="Code List - Specimen"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>PLASMA [<span class="nci">C13356</span>]</td></tr><tr class="tableroweven"><td>SERUM [<span class="nci">C13325</span>]</td></tr><tr class="tablerowodd"><td>URINE [<span class="nci">C13283</span>]</td></tr><tr class="tableroweven"><td>WHOLE BLOOD [<span class="nci">C41067</span>]</td></tr></table></div><div class="codelist" id="CL.SPECIES"><div class="codelist-caption">Species [<span class="nci">C77808</span>]</div><table summary="Code List - Species"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>MONKEY [<span class="nci">C14243</span>]</td></tr></table></div><div class="codelist" id="CL.SSTYP"><div class="codelist-caption">SEND Study Type [<span class="nci">C90003</span>]</div><table summary="Code List - SEND Study Type"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>REPEAT DOSE TOXICITY [<span class="nci">C79376</span>]</td></tr></table></div><div class="codelist" id="CL.STCAT"><div class="codelist-caption">Study Category [<span class="nci">C90002</span>]</div><table summary="Code List - Study Category"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>TOX [<span class="nci">C17206</span>]</td></tr></table></div><div class="codelist" id="CL.STRAIN"><div class="codelist-caption">Strain/Substrain [<span class="nci">C77530</span>]</div><table summary="Code List - Strain/Substrain"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>CYNOMOLGUS [<span class="nci">C14232</span>]</td></tr></table></div><div class="codelist" id="CL.STSPRM"><div class="codelist-caption">SEND Trial Summary Parameter Test Name [<span class="nci">C90007</span>]</div><table summary="Code List - SEND Trial Summary Parameter Test Name"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Age Text [<span class="nci">C90352</span>]</td></tr><tr class="tableroweven"><td>Age Unit [<span class="nci">C50400</span>]</td></tr><tr class="tablerowodd"><td>Arm Code [<span class="nci">C83216</span>]</td></tr><tr class="tableroweven"><td>Dose Level [<span class="nci">C25488</span>]</td></tr><tr class="tablerowodd"><td>Dose Units [<span class="nci">C73558</span>]</td></tr><tr class="tableroweven"><td>Dosing Duration [<span class="nci">C90378</span>]</td></tr><tr class="tablerowodd"><td>Experimental End Date [<span class="nci">C90382</span>]</td></tr><tr class="tableroweven"><td>Experimental Start Date [<span class="nci">C90487</span>]</td></tr><tr class="tablerowodd"><td>Good Laboratory Practice Type [<span class="nci">C90389</span>]</td></tr><tr class="tableroweven"><td>Group Label [<span class="nci">C90391</span>]</td></tr><tr class="tablerowodd"><td>Housing Group [<span class="nci">C90394</span>]</td></tr><tr class="tableroweven"><td>Investigational Therapy or Treatment [<span class="nci">C41161</span>]</td></tr><tr class="tablerowodd"><td>Planned Number of Female Subjects [<span class="nci">C90437</span>]</td></tr><tr class="tableroweven"><td>Planned Number of Subjects [<span class="nci">C95106</span>]</td></tr><tr class="tablerowodd"><td>Primary Treatment CAS Registry Number [<span class="nci">C92645</span>]</td></tr><tr class="tableroweven"><td>Route of Administration [<span class="nci">C38114</span>]</td></tr><tr class="tablerowodd"><td>SEND Controlled Terminology Version [<span class="nci">C96370</span>]</td></tr><tr class="tableroweven"><td>SEND Implementation Guide Version [<span class="nci">C90458</span>]</td></tr><tr class="tablerowodd"><td>Sex of Participants [<span class="nci">C49696</span>]</td></tr><tr class="tableroweven"><td>Species [<span class="nci">C96433</span>]</td></tr><tr class="tablerowodd"><td>Sponsor's Study Reference ID [<span class="nci">C135009</span>]</td></tr><tr class="tableroweven"><td>Sponsor-Defined Group Code [<span class="nci">C90456</span>]</td></tr><tr class="tablerowodd"><td>Sponsoring Organization [<span class="nci">C129946</span>]</td></tr><tr class="tableroweven"><td>Strain/Substrain [<span class="nci">C96373</span>]</td></tr><tr class="tablerowodd"><td>Study Category [<span class="nci">C90461</span>]</td></tr><tr class="tableroweven"><td>Study Design [<span class="nci">C95082</span>]</td></tr><tr class="tablerowodd"><td>Study Director [<span class="nci">C129944</span>]</td></tr><tr class="tableroweven"><td>Study End Date [<span class="nci">C99156</span>]</td></tr><tr class="tablerowodd"><td>Study Length [<span class="nci">C95105</span>]</td></tr><tr class="tableroweven"><td>Study Start Date [<span class="nci">C99157</span>]</td></tr><tr class="tablerowodd"><td>Study Title [<span class="nci">C95108</span>]</td></tr><tr class="tableroweven"><td>Study Type [<span class="nci">C92644</span>]</td></tr><tr class="tablerowodd"><td>Test Facility Country [<span class="nci">C90467</span>]</td></tr><tr class="tableroweven"><td>Test Facility Location [<span class="nci">C90468</span>]</td></tr><tr class="tablerowodd"><td>Test Facility Name [<span class="nci">C90469</span>]</td></tr><tr class="tableroweven"><td>Test Subject Supplier [<span class="nci">C90473</span>]</td></tr><tr class="tablerowodd"><td>Time to Terminal Sacrifice [<span class="nci">C90466</span>]</td></tr><tr class="tableroweven"><td>Treatment Vehicle [<span class="nci">C927</span>]</td></tr></table></div><div class="codelist" id="CL.STSPRMCD"><div class="codelist-caption">SEND Trial Summary Parameter Test Code [<span class="nci">C90009</span>]</div><table summary="Controlled Term - SEND Trial Summary Parameter Test Code"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AGETXT [<span class="nci">C90352</span>]</td><td class="codelist-item-decode">A textual representation of a chronological age. (NCI)</td></tr><tr class="tableroweven"><td>AGEU [<span class="nci">C50400</span>]</td><td class="codelist-item-decode">Those units of time that are routinely used to express the age of a person. (NCI)</td></tr><tr class="tablerowodd"><td>ARMCD [<span class="nci">C83216</span>]</td><td class="codelist-item-decode">A character or string that represents a planned arm of a trial or study.</td></tr><tr class="tableroweven"><td>DOSDUR [<span class="nci">C90378</span>]</td><td class="codelist-item-decode">The interval of time over which a course of doses occurs. (NCI)</td></tr><tr class="tablerowodd"><td>EXPENDTC [<span class="nci">C90382</span>]</td><td class="codelist-item-decode">Experimental completion date means the last date on which data are collected from the study. (OECD)</td></tr><tr class="tableroweven"><td>EXPSTDTC [<span class="nci">C90487</span>]</td><td class="codelist-item-decode">Experimental starting date means the date on which the first study specific data are collected. (OECD)</td></tr><tr class="tablerowodd"><td>GLPTYP [<span class="nci">C90389</span>]</td><td class="codelist-item-decode">A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. (OECD)</td></tr><tr class="tableroweven"><td>GRPLBL [<span class="nci">C90391</span>]</td><td class="codelist-item-decode">Alpha-numeric character(s) assigned to identify a particular collection of subjects possessing common characteristic(s).</td></tr><tr class="tablerowodd"><td>HOUSEGRP [<span class="nci">C90394</span>]</td><td class="codelist-item-decode">A classification of a group of animals based upon their shared living space.</td></tr><tr class="tableroweven"><td>PLANFSUB [<span class="nci">C90437</span>]</td><td class="codelist-item-decode">The intended quantity of female subjects.</td></tr><tr class="tablerowodd"><td>ROUTE [<span class="nci">C38114</span>]</td><td class="codelist-item-decode">The course by which a substance is administered in order to reach the site of action in the body.</td></tr><tr class="tableroweven"><td>SDESIGN [<span class="nci">C95082</span>]</td><td class="codelist-item-decode">A plan detailing how a trial or study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and defining the methods of data analysis. Study design is driven by the research hypothesis being posed, study subject/population/sample available, logistics/resources: technology, support, networking, collaborative support, etc.</td></tr><tr class="tablerowodd"><td>SEXPOP [<span class="nci">C49696</span>]</td><td class="codelist-item-decode">The specific sex, either male, female, or mixed of the subject group being studied. (NCI)</td></tr><tr class="tableroweven"><td>SLENGTH [<span class="nci">C95105</span>]</td><td class="codelist-item-decode">The anticipated length of a nonclinical study measured as a unit of time. (NCI)</td></tr><tr class="tablerowodd"><td>SNDCTVER [<span class="nci">C96370</span>]</td><td class="codelist-item-decode">The version of the Standard for the Exchange of Nonclinical Data Controlled Terminology that is being used in the study.</td></tr><tr class="tableroweven"><td>SNDIGVER [<span class="nci">C90458</span>]</td><td class="codelist-item-decode">The version of the Standard for the Exchange of Nonclinical Data Implementation Guide that is being used in the study submission.</td></tr><tr class="tablerowodd"><td>SPECIES [<span class="nci">C96433</span>]</td><td class="codelist-item-decode">The common name for an animal used as the test system on a study (e.g., dog, monkey, mouse, rabbit, rat).</td></tr><tr class="tableroweven"><td>SPGRPCD [<span class="nci">C90456</span>]</td><td class="codelist-item-decode">Alpha-numeric character(s) assigned by the sponsor to identify a particular collection of subjects possessing common characteristic(s).</td></tr><tr class="tablerowodd"><td>SPLANSUB [<span class="nci">C95106</span>]</td><td class="codelist-item-decode">The planned number of subjects to be entered in a nonclinical study.</td></tr><tr class="tableroweven"><td>SPLRNAM [<span class="nci">C90473</span>]</td><td class="codelist-item-decode">The name of the organization that supplied the test subjects. (NCI)</td></tr><tr class="tablerowodd"><td>SPREFID [<span class="nci">C135009</span>]</td><td class="codelist-item-decode">The reference identifier by which the study is known to the sponsor. This may be different from the STUDYID if the data were collected under a different identifier in the GLP protocol (e.g., used in a situation where a contract facility performs the study and provides a final report).</td></tr><tr class="tableroweven"><td>SSPONSOR [<span class="nci">C129946</span>]</td><td class="codelist-item-decode">The name of the entity that is responsible for the initiation, management, and/or financing of a nonclinical study. (NCI)</td></tr><tr class="tablerowodd"><td>SSTYP [<span class="nci">C92644</span>]</td><td class="codelist-item-decode">The type of nonclinical study performed e.g. Single Dose, Repeat Dose. (NCI)</td></tr><tr class="tableroweven"><td>STCAT [<span class="nci">C90461</span>]</td><td class="codelist-item-decode">The classification of the study. (NCI)</td></tr><tr class="tablerowodd"><td>STDIR [<span class="nci">C129944</span>]</td><td class="codelist-item-decode">The name of the person who has overall responsibility for the technical conduct of a study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (FDA)</td></tr><tr class="tableroweven"><td>STENDTC [<span class="nci">C99156</span>]</td><td class="codelist-item-decode">The date on which the final report is signed by the study director. Also known as Study Completion Date. (FDA)</td></tr><tr class="tablerowodd"><td>STITLE [<span class="nci">C95108</span>]</td><td class="codelist-item-decode">The name of a nonclinical study.</td></tr><tr class="tableroweven"><td>STRAIN [<span class="nci">C96373</span>]</td><td class="codelist-item-decode">The vendor-supplied species/strain/substrain designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g. FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS and CHIMPANZEE).</td></tr><tr class="tablerowodd"><td>STSTDTC [<span class="nci">C99157</span>]</td><td class="codelist-item-decode">The date on which the protocol is signed by the study director. Also known as Study Initiation Date. (FDA)</td></tr><tr class="tableroweven"><td>TFCNTRY [<span class="nci">C90467</span>]</td><td class="codelist-item-decode">The country of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)</td></tr><tr class="tablerowodd"><td>TRMSAC [<span class="nci">C90466</span>]</td><td class="codelist-item-decode">The duration from the start of dosing to the final sacrifice of the subject. (NCI)</td></tr><tr class="tableroweven"><td>TRT [<span class="nci">C41161</span>]</td><td class="codelist-item-decode">The investigational product under study.</td></tr><tr class="tablerowodd"><td>TRTCAS [<span class="nci">C92645</span>]</td><td class="codelist-item-decode">The Chemical Abstract Service registry number of the investigational product (test article).</td></tr><tr class="tableroweven"><td>TRTDOS [<span class="nci">C25488</span>]</td><td class="codelist-item-decode">The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary)</td></tr><tr class="tablerowodd"><td>TRTDOSU [<span class="nci">C73558</span>]</td><td class="codelist-item-decode">The unit of measure for the dosage form.</td></tr><tr class="tableroweven"><td>TRTV [<span class="nci">C927</span>]</td><td class="codelist-item-decode">A carrier or inert medium used as a solvent (or diluent) in which a medicinally active agent is formulated and or administered. (NCI)</td></tr><tr class="tablerowodd"><td>TSTFLOC [<span class="nci">C90468</span>]</td><td class="codelist-item-decode">The geographic area of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)</td></tr><tr class="tableroweven"><td>TSTFNAM [<span class="nci">C90469</span>]</td><td class="codelist-item-decode">The name of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)</td></tr></table></div><div class="codelist" id="CL.UNIT"><div class="codelist-caption">Unit [<span class="nci">C71620</span>]</div><table summary="Code List - Unit"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>% [<span class="nci">C25613</span>]</td></tr><tr class="tableroweven"><td>10^12/L [<span class="nci">C67308</span>]</td></tr><tr class="tablerowodd"><td>10^9/L [<span class="nci">C67255</span>]</td></tr><tr class="tableroweven"><td>U/L [<span class="nci">C67456</span>]</td></tr><tr class="tablerowodd"><td>fL [<span class="nci">C64780</span>]</td></tr><tr class="tableroweven"><td>g [<span class="nci">C48155</span>]</td></tr><tr class="tablerowodd"><td>g/dL [<span class="nci">C64783</span>]</td></tr><tr class="tableroweven"><td>kg [<span class="nci">C28252</span>]</td></tr><tr class="tablerowodd"><td>mL [<span class="nci">C28254</span>]</td></tr><tr class="tableroweven"><td>mg/dL [<span class="nci">C67015</span>]</td></tr><tr class="tablerowodd"><td>mmol/L [<span class="nci">C64387</span>]</td></tr><tr class="tableroweven"><td>pg [<span class="nci">C64551</span>]</td></tr><tr class="tablerowodd"><td>sec [<span class="nci">C42535</span>]</td></tr><tr class="tableroweven"><td>ug/dose [<span class="nci">C124462</span>]</td></tr></table></div><div class="codelist" id="CL.CL.fe7e121a-b0cc-4796"><div class="codelist-caption">ISTEST</div><table summary="Code List - ISTEST"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>HBsAg IgM</td></tr><tr class="tableroweven"><td>HBsAg IgG</td></tr></table></div><div class="codelist" id="CL.CL.86d1da8a-8d6c-4216"><div class="codelist-caption">ISTESTCD</div><table summary="Controlled Term - ISTESTCD"><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>IGMHBA</td><td class="codelist-item-decode">Hepatitis B Vaccine (HBsAg) IgM Serum Analysis</td></tr><tr class="tableroweven"><td>IGGHBA</td><td class="codelist-item-decode">Hepatitis B Vaccine (HBsAg) IgG Serum Analysis</td></tr></table></div><div class="codelist" id="CL.CL.d2fca64d-a119-4bce"><div class="codelist-caption">IS.UNIT [<span class="nci">C71620</span>]</div><table summary="Code List - IS.UNIT"><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>U/mL [<span class="nci">C124462</span>]</td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div><a id="compmethod"></a><div class="containerbox"><h1 class="invisible">Methods</h1><table summary="Methods"><caption class="header">Methods</caption><tr class="header"><th scope="col">Method</th><th scope="col">Type</th><th scope="col">Description</th></tr><tr id="MT.MT.198dd982-83df-4c2f" class="tablerowodd"><td>VISITDY</td><td>Computation</td><td><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr><tr id="MT.MT.492f0579-b8b4-46d7" class="tableroweven"><td>BLFL</td><td>Computation</td><td><div class="method-code">Last non-null predose observation per subject per test</div></td></tr><tr id="MT.MT.55d89e07-ae3d-4af3" class="tablerowodd"><td>ENDY</td><td>Computation</td><td><div class="method-code">Calculated based on End Date/Time of Animal Weighed minus Subject Reference Start Date/Time, plus one when occurring after Day 1. 
</div></td></tr><tr id="MT.MT.5df06289-8457-4ce2" class="tableroweven"><td>DY</td><td>Computation</td><td><div class="method-code">Calculated based on Date/Time of Observation minus Subject Reference Start Date/Time, plus one when occurring after Day 1.  
</div></td></tr><tr id="MT.MT.8c39d4b3-9f3b-4e22" class="tablerowodd"><td>NOMLBL</td><td>Computation</td><td><div class="method-code">Populated with the phase name and the planned date of data collection, in days from the phase start date.
</div></td></tr><tr id="MT.MT.cbb773ad-9a50-463e" class="tableroweven"><td>NOMDY</td><td>Computation</td><td><div class="method-code">Calculated based on the planned date of data collection, in days from the Subject Reference Start Date/Time, plus one when occurring after Day 1.
</div></td></tr></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div></body></html>